Prophylactic Fenestration of the Peritoneum in Kidney Transplantation
PROFFEN
Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative Lymphoceles
1 other identifier
interventional
130
1 country
1
Brief Summary
A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation. Adult (\>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 21, 2010
CompletedFirst Posted
Study publicly available on registry
September 22, 2010
CompletedSeptember 22, 2010
March 1, 2007
September 21, 2010
September 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of symptomatic lymphoceles
Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage
1 - 3 years
Secondary Outcomes (1)
Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks
1 -10 weeks
Study Arms (2)
Fenestration
ACTIVE COMPARATORFenestration of the peritoneum according to the length of the transplanted kidney
Control
SHAM COMPARATORStandard kidney transplantation
Interventions
Fenestration of the peritoneum according to the length of the transplanted kidney
Eligibility Criteria
You may qualify if:
- Adult recipients of kidney transplants from deceased donors
You may not qualify if:
- Former extensive abdominal surgery
- Participation in other studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, 0027, Norway
Related Publications (1)
Syversveen T, Midtvedt K, Brabrand K, Oyen O, Foss A, Scholz T. Prophylactic peritoneal fenestration to prevent morbidity after kidney transplantation: a randomized study. Transplantation. 2011 Jul 27;92(2):196-202. doi: 10.1097/TP.0b013e318220f57b.
PMID: 21597401DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 21, 2010
First Posted
September 22, 2010
Study Start
March 1, 2007
Study Completion
May 1, 2009
Last Updated
September 22, 2010
Record last verified: 2007-03